3-morpholinopropylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-02-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-morpholinopropylamine

EC Number:

204-590-2

EC Name:

3-morpholinopropylamine

Cas Number:

123-00-2

Molecular formula:

C7H16N2O

IUPAC Name:

3-morpholin-4-ylpropan-1-amine

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: no data
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable, the test item was dosed as received.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: one female New Zealand White rabbit; Hazleton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.264 kilograms
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council.. Waste material was removed twice weekly. Cages and feeders are sanitized every two weeks.
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow(R) H.F., checked daily and added or replaced as needed according to S.O.P PH-113. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): ad libitum, fresh tap water
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/treated eye

Duration of treatment / exposure:

single application

Observation period (in vivo):

1 hour

Number of animals or in vitro replicates:

1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
- Grading of irritation is done according to Draize.
- The eye was examined one hour after treatment.

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 1 hour

Score:

3

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

other: 1 hour

Score:

3

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 hour

Score:

4

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 hour

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Extreme positive ocular responses for the cornea, iris and conjuctivae were observed at the 1-hour observation period. A red ocular discharge was also observed at this observation period. Due to the extreme ocular scores observed, the study was terminated at the study director's discretion after the 1-hour observation period.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the observation made in the Primary Eye Irritation Study, the test article was determined to be a severe irritant. According to the criteria of the CLP Regulation the test article is classified for eye damage category 1.